mHealth to Increase Measles Immunization - a Randomized Controlled Trial in Guinea-Bissau

Measles Clinical Trial

— mimi  

Official title:

Mimi - mHealth to Increase Measles Immunization. A Randomized Controlled Trial.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02662595
• Other study ID #: MIMI-01
• Status: Not yet recruiting
• Phase: N/A
• First received: January 20, 2016
• Last updated: January 22, 2016
• Start date: March 2016
• Est. completion date: January 2018

Study information

• Verified date: January 2016
• Source: Bandim Health Project
• Contact: Emil Rossing, MA
• Phone: +2455772149
• Email: emro[@]ssi.dk
• Is FDA regulated: No
• Health authority: Guinea-Bissau: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

The question that this project seeks to answer, is whether mobile phones can be used to increase the measles vaccination coverage and timeliness in Guinea-Bissau. The intervention will be evaluated in terms of direct health outcomes and cost/benefit analysis, generating evidence that could help policy makers making informed decisions about implementing mHealth interventions at a national level.

The intervention takes the form of a randomized controlled trial in which text messages (SMS) as well as voice calls are scheduled and delivered to mo thers to remind and encourage them to have their children timely vaccinated against measles. In addition, the messages will include relevant information about opening hours and availability of the measles vaccine at the mothers' local health facilities thus improving coordination. The trial will include three different randomization groups with approx. 350 participants in each group. The first group will receive SMS messages, the second group will receive a voice call in addition to the SMS messages, and the third group is a control group that does not receive any intervention.

Study participants will be enrolled following birth at one of three health centers in different rural regions of Guinea-Bissau. Before the measles vaccine is scheduled to be given, at 9 months of age, mothers will receive the intervention message depending on their assigned randomization group. When the measles vaccine is administered, the child will be registered as having received the measles vaccination.

A follow-up phone interview will be conducted at 12 months of age for all children participating regardless of randomization group and whether or not they received the measles vaccine. All participating children, who at that time still have not received the measles vaccine, will be offered the vaccine at the expense of the project.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 1050
• Est. completion date: January 2018
• Est. primary completion date: January 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A to 3 Months

Eligibility

Inclusion Criteria:

• the mother has access to a cell phone (either her own phone or the phone of a household member)

• the mother lives in the uptake area of the health center.

Exclusion Criteria:

• the mother does not have access to a mobile phone.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Caregiver, Investigator), Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Measles

Intervention

Other:
• SMS reminder message

• Voice call + SMS message

Locations

Country	Name	City	State
Guinea-Bissau	Catio Health Center	Catío	Tombali
Guinea-Bissau	Paunca Health Center	Paunca	Gabú
Guinea-Bissau	Varela Health Center	Varela	Cacheu

Sponsors (1)

Lead Sponsor	Collaborator
Bandim Health Project

Country where clinical trial is conducted

Guinea-Bissau, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	MV Coverage at 12 months of age	Difference in measles vaccination coverage at 12 months of age between the intervention and the control groups.	12 months of age	No
Secondary	Timeliness	Difference in timeliness of measles vaccines administered, measured as median age of measles vaccinated children.	At 12 months	No
Secondary	Average number of visits	Average number of visits to the health center with the purpose of receiving MV needed before MV is successfully administered.	At 12 months	No